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Notice under subsection 42ZCZN/42ZCZP of the Therapeutic Goods Regulations 1990 (the Regulations)

This consultation closed on 3 October 2017

In accordance with subsection 42ZCZN of the Regulations, the delegate of the Secretary to the Department of Health has made an interim decision in relation to a proposed amendment; and under subsection 42ZCZP of the Regulations hereby gives notice of the delegates' interim decisions for amending the Poisons Standard (the Standard for the Uniform Scheduling of Medicines and Poisons - SUSMP). This notice also provides the reasons and the date of effect (the implementation date) for each decision.

The delegate's interim decisions and reasons related to:

scheduling proposals initially referred to the July 2017 meeting of the Advisory Committee on Medicines Scheduling (ACMS #21);

scheduling proposals initially referred to the March 2017 and July 2017 Joint meeting of the Advisory Committees on Chemicals and Medicines Scheduling (ACCS-ACMS #15 and #16 respectively); and

scheduling proposals initially referred to the July 2017 meeting of the Advisory Committee on Chemicals Scheduling (ACCS #20).

Pre-meeting public notices

On 22 December 2016, 3 February 2017, 17 May 2017 and 7 June 2017, under subsection 42ZCZK of the Therapeutic Goods Regulations 1990 (the Regulations), the delegate published a pre-meeting public notice on the TGA website which specified the proposed amendments to the current Poisons Standard. The notice also invited public comment on the scheduling proposals referred to the expert advisory committees.

The pre-meeting consultation period was open for public comment for 20 business days and closed on 10 February 2017, 3 March 2017, 15 June 2017 and 7 July 2017.

In accordance with subsection 42ZCZL of the Regulations, redacted versions of public submissions received in response to this invitation for public comment will be published on or after the date of this notice on the TGA website at Public submissions on scheduling matters.

Interim decisions

In accordance with subsections 42ZCZN and 42ZCZP of the Regulations, this notice provides the interim decisions of the delegates and the reasons for those decisions and invites further submissions from the applicant and parties who made valid submissions in response to the original invitations for submissions (see Pre-meeting public notices above).

Further submissions must be relevant to the proposed amendment, must address a matter mentioned in section 52E of the Therapeutic Goods Act 1989 and be received by the closing date, 3 October 2017.

Further submissions from parties other than those who made a valid submission in response to the original invitation or the applicant, or those received after the closing date, need not be considered by the delegate.

Please note that all valid submissions received on or before the closing date will be published following removal of confidential information. It is up to the person making the submissions to highlight any information that they wish to be considered as confidential. Material claimed to be commercial-in-confidence will be considered against the guidelines for the use and release of confidential information set out in Chapter 6 of the Scheduling Policy Framework for Medicines and Chemicals (SPF, 2015), issued by the Australian Health Ministers' Advisory Council (AHMAC). The SPF is accessible at: AHMAC - Scheduling policy framework for medicines and chemicals.

Persons making submissions are strongly encouraged to lodge submissions in electronic format (word or unsecured PDF preferred) via the email address provided below. Submissions, preferably in electronic format, should be made to:

Privacy and your personal information

Your personal information is protected by law, including the Privacy Act 1988. It is collected by the Australian Government Department of Health for the purposes of identifying the person making a submission as part of the public invitation process, and contacting that person about their submission, for example to seek clarification of issues raised in the submissions.

The consequences of not providing your personal information may result in the Department being unable to communicate with you about your submission.

The Department is unlikely to disclose your personal information it has collected as part of the public comment process to any other Department, body or person or to overseas recipients.

More information about the Department's management of personal information is contained in the Department's privacy policy. The Department's privacy policy contains information such as how you may access the personal information the Department holds about you, how you can seek correction of it, and how you may complain about a breach of the Australian Privacy Principles.